Importance of BMR 

  1. Manufacturing records are required to provide a List of raw materials and their quantities obtained from the stores.
  2. Quality and Safety: They ensure the quality and safety of pharmaceutical production.
  3. Detailed Documentation: They provide detailed documentation of production processes.
  4. Proof of Compliance: They offer proof that a particular product batch was manufactured according to the procedures detailed in the master formula record.
  5. Quality Standards: They establish a product’s quality standards.
  6. Legal Evidence: They provide legal evidence that the company followed Good Manufacturing Practices (GMP).

Importance of MFR

  1. Reference Standard: The MFR is used as a reference standard for preparing the Batch Manufacturing Record (BMR) by manufacturing units.
  2. It provides proof that a particular product batch was manufactured according to the procedures detailed in the master formula record
  3. Uniformity Across Batches: The MFR ensures that there is uniformity across batches of the same product.
  4. Comprehensive Information: The MFR contains all information about the manufacturing process for a product. It’s prepared by the research and development team of the company. 
  5. Detailed instruction and precautions to be taken in manufacturer and storage of drug are there in MFR.
  6. It gives an idea about the theoretical yield of a formulation to be expected at different stages of manufacture. 
  7. It contains all description of vessels and equipments used in the process. 

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